ALLEVYN AG GENTLE BORDER 10 X 10 CM 66800461

GUDID 05000223465995

Silicone gel adhesive hydrocellular foam dressing with Silver

SMITH & NEPHEW MEDICAL LIMITED

Wound-nonadherent dressing, absorbent, antimicrobial

• Primary Device ID: 05000223465995
• NIH Device Record Key: a34c0981-7f29-413f-9e5c-4e15d772c75b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALLEVYN AG GENTLE BORDER 10 X 10 CM
• Version Model Number: 66800461
• Catalog Number: 66800461
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05000223465988 [Primary]
GS1	05000223465995 [Package]; Contains: 05000223465988; Package: carton [10 Units]; In Commercial Distribution
GS1	05000223466008 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063835

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-25
• Device Publish Date: 2020-05-15

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